Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
In Reply Because our study was a phase 2B trial with the purpose of finding the optimal dosage with which to conduct a phase 3 outcome trial, strong conclusions should not be drawn from the results. Although Dr Feng and colleagues are correct that change in UACR at day 90 was the primary end point, we understand this is not consistent with any valid renal outcome and is a marker of inflammation and cardiovascular risk rather than renal injury.1 We are fully aware of the variable relationship of high albuminuria and both kidney disease and cardiovascular outcomes from powered trials.
Bakris GL, Nowack C. Finerenone for Albuminuria in Patients With Diabetic Nephropathy—Reply. JAMA. 2016;315(3):306. doi:10.1001/jama.2015.16014